Betnovate 0.1% cream

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Betamethasone valerate

Dostępny od:

GlaxoSmithKline UK Ltd

Kod ATC:

D07AC01

INN (International Nazwa):

Betamethasone valerate

Dawkowanie:

1mg/1gram

Forma farmaceutyczna:

Cutaneous cream

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 13040000; GTIN: 5000123107148 5000123101054

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE CREAM
BETAMETHASONE VALERATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Betnovate is and what it is used for
2
What you need to know before you use Betnovate
3
How to use Betnovate
4
Possible side effects
5
How to store Betnovate
6
Contents of the pack and other information
1
WHAT BETNOVATE IS AND WHAT IT IS USED FOR
Betnovate contains a medicine called betamethasone valerate. It
belongs to a
group of medicines called steroids that reduce swelling and
irritation.
Betnovate is used to help reduce the redness and itchiness of certain
skin
problems, such as eczema, psoriasis and dermatitis.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BETNOVATE
DO NOT USE BETNOVATE:

if you are allergic (hypersensitive) to betamethasone valerate or any
of the
other ingredients of Betnovate (listed in section 6)

on a child under 1 year

to treat any of the following skin problems, it could make them worse:
-
acne
-
severe flushing of skin on and around your nose (rosacea)
-
spotty red rash around your mouth (perioral dermatitis)
-
itching around your back passage or private parts
-
infected skin (unless the infection is being treated with an
anti-infective
medicine at the same time)
-
itchy skin which is not inflamed
Do not use if any of the above apply to you. If you are not sure, talk
to your
doctor or pharmacist before using Betnovate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Betnovate if:

you have previously had

Charakterystyka produktu

OBJECT 1
BETNOVATE CREAM
Summary of Product Characteristics Updated 13-Sep-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Betnovate Cream
2. Qualitative and quantitative composition
Betamethasone Valerate BP 0.122%
W
/
W
Excipients with known effect:
Chlorocresol
Cetostearyl alcohol
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Aqueous Cream
4. Clinical particulars
4.1 Therapeutic indications
Betamethasone valerate is a potent topical corticosteroid indicated
for adults, elderly and children over 1
year for the relief of the inflammatory and pruritic manifestations of
steroid responsive dermatoses. These
include the following:
Atopic dermatitis (including infantile atopic dermatitis)
Nummular dermatitis (discoid eczema)
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Lichen simplex chronicus (neurodermatitis) and lichen planus
Seborrhoeic dermatitis
Irritant or allergic contact dermatitis
Discoid lupus erythematosus
Adjunct to systemic steroid therapy in generalised erythroderma
Insect bite reactions
4.2 Posology and method of administration
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice daily for
up to 4 weeks until improvement occurs, then reduce the frequency of
application or change the treatment
to a less potent preparation.
Allow adequate time for absorption after each application before
applying an emollient.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and knees, the effect of
betamethasone valerate can be enhanced, if necessary, by occluding the
treatment area with polythene
film. Overnight occlusion only is usually adequate to bring about a
satisfactory response in such lesions;
thereafter, improvement can usually be maintained by regular
application without occlusion.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis should